Portable automatic brain state assessment apparatus

ABSTRACT

A method and apparatus for performing rapid brain assessment may provide emergency triage to head trauma patients by analyzing a combination of spontaneous and evoked brain potentials. The spontaneous and evoked potentials are analyzed, and the results classified, to present a real-time assessment of a patient&#39;s brain, diagnosing any potential abnormalities therein.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. application Ser. No.11/195,001, filed Aug. 2, 2005, now U.S. Pat. No. 7,904,144, the entirecontent of which is incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to the field of emergency triage, andspecifically, a method and apparatus for performing emergencyneurological triage. Moreover, the invention relates to a method andapparatus for assessing brain function.

BACKGROUND OF THE INVENTION

The central nervous system (CNS) and the brain in particular, performthe most complex and essential processes in the human body.Surprisingly, contemporary health care lacks sophisticated tools toobjectively assess their function. A patient's mental and neurologicalstatus is typically assessed clinically by an interview and a subjectivephysical exam. The clinical laboratory currently has no capacity toassess brain function or pathology, contributing little more thanidentification of poisons, toxins, or drugs that may have externallyimpacted the CNS. Brain imaging studies, such as computed tomographyimaging (CT), magnetic resonance imaging (MRI), though widely used anduseful, are structural/anatomical tests revealing little or nothingabout brain function. In the immediate time of acute brain injury,stroke, or seizure, imaging studies typically reveal no abnormality,even when there is clear and dramatically abnormal brain function. CTand MRI only detect the condition after the morphology or structure ofthe brain has changed. In some cases it can take from hours to daysafter the patient is present in an emergency room (ER) before overtchanges are evident on the CT or MRI, and before severe neurologicalpathology is visible. Electrical activity of the brain, however, isaffected immediately. New imaging modalities such as functional MRI(fMRI) measure the changes in oxygen saturation in different parts ofthe brain. Radioisotope imaging such as positron emission tomography(PET) and single photon emission computerized tomography (SPECT) assesschemical changes within the brain as a measurement of function withlimited sensitivity and specificity. All of these assessment tools playan important role in selected cases, but they are costly, notuniversally available, and they do not provide critical information atthe early stages of acute care situations. None of the currenttechniques provides the immediate, actionable information critical totimely intervention, appropriate triage, or the formulation of anappropriate plan of care.

The CNS and brain, of all organs in the human body, are also the mosttime sensitive and have the least capacity for repair. Currently,emergency room patients with altered mental status, acute neuropathy, orhead trauma must undergo costly and time consuming tests to determine anappropriate course of treatment. Unfortunately, in many cases, theclinical condition of patients continue to deteriorate as they wait forequipment to become available or for specialists to interpret tests. Thetask of the ER physician is to basically establish whether the brain isfunctioning normally, whether the abnormality is psychiatric or organicin nature, whether an organic abnormality is global or lateralized, andto develop an initial assessment of the diagnostic possibilities. Theproblem that faces ER physicians is that their resources are quiteliterally limited to a flashlight and a rubber reflex hammer. Amazingly,all of the physician's decisions concerning the administration ofemergency treatment or intervention, including CT scan, spinal tap,additional consultation or discharge are based on the results of thissimplistic exam.

Often, ER patients are sent for imaging studies, yet many functionalbrain abnormalities, such as seizure, are not visible on a CT scan. Someabnormalities which will eventually have anatomical and structuralconsequences often take time to become visible. This is true for manyimportant conditions such as ischemic stroke, concussion, raisedintracranial pressure, and others. Thus, while the location, expense,and limited availability of the CT scan can be problematic, so indeedcan the fact that it is a structural as opposed to functional test.

One-third of over 200 physicians surveyed at the American College ofEmergency Physicians feel that the combination of a good clinicallaboratory, a neurological exam, and a CT scan of the head, is notadequate for the assessment of every patient with altered mental statusor neurological dysfunction. Consensus estimates from the CDC NHSdatabase and practicing ER physicians, is that patients requiring amental status exam represent 15% of the more than 100 million ER visitsannually in the U.S., and in some institutions, considerably more.

There are more than 100 million ER visits per year in the US alone(CDC/NCHS) database. In year 2000, more than 13 million of thesepatients required a formal mental status exam and nearly 5 million hadCT scans. This data indicates the need for real-time functional brainstate assessment which can be performed in the hospital, in anambulance, at a sporting event, or any other location where acuteneurological evaluation may be necessary.

All of the brain's activity, whether reflexive, automatic, unconscious,or conscious, is electrical in nature. Through a series ofelectro-chemical reactions, mediated by molecules calledneurotransmitters, electrical potentials (voltages) are generated andtransmitted throughout the brain, traveling continuously between andamong the myriad of neurons. This activity establishes the basicelectrical signatures of the electroencephalogram (EEG) and createsidentifiable frequencies which have a basis in anatomic structure andfunction. Understanding these basic rhythms and their significance makesit possible to characterize the EEG as being within or beyond normallimits. At this basic level, the EEG serves as a signature for bothnormal and abnormal brain function.

The electrical activity of the brain has been studied extensively sincethe first recordings over 75 years ago, and especially since the adventof computers. “Normal” electrical activity of the brain has been wellcharacterized in hundreds of studies, with a narrow standard deviation.The frequencies of electrical activity of some parts of the brain arethe normal response to various stimuli, such as acoustic, visual, orpain, known as “evoked potentials.” Evoked potentials (EP) areparticular waves that have characteristic shapes, amplitudes andduration of peaks within those wave shapes, and many other features, allof which have well established normative data, generated over decades ofresearch. Normative data for all of the EEG and evoked response wavesare remarkably constant across different genders, ages, and ethnicities.Moreover, any variability that does exist is well described andexplained.

Neuroscientists have also characterized the EEG signature of variousdifferent brain pathologies. Just as an abnormal electrocardiogram (ECG)pattern is a strong indication of a particular heart pathology, anirregular brain wave pattern is a strong indication of a particularbrain pathology. A wide array of pathologies have been wellcharacterized: acute and chronic, structural, toxic, metabolic, and evenspecific diagnoses such as: ischemic stroke, epileptic seizures,concussion, alcohol, and drug overdose, psychiatric conditions, anddementias including Alzheimer's disease. A large body of data, withcontinuing refinements and contributions, constitutes the field ofclinical neurophysiology.

Even though EEG-based neurometric technology is accepted today and atremendous body of data exists, application in the clinical environmentis notably limited. Some of the barriers limiting its adoption include:the cost of EEG equipment, its lack of portability, the need for atechnician to administer the test, the time it takes to conduct thetest, and the need for expert interpretation of the raw data. Moreimportantly, the technology is neither available nor practical in theacute care setting, especially at the point of care. A completediagnostic EEG instrument typically costs $80,000, fully equipped.Despite the high costs, the instrument produces essentially rawwaveforms which must be carefully interpreted by an expert. Moreover,use of the standard EEG equipment remains extremely cumbersome. It cantake 30 minutes or more to apply the required 19 electrodes. Once thepatient is prepared for the test, the recording itself can take from 1to 4 hours. Data is collected and analyzed by an EEG technician, and arethen presented to a neurologist for interpretation and clinicalassessment. There are some self-standing dedicated neurodiagnosticlaboratories which focus strictly on detailed analysis of electricalbrain data. Neither the specialized centers, nor the typically largehospital EEG machines are practical for the ER, operating room (OR),intensive care unit (ICU), or any other acute care medicine settingwhere patients are in the greatest need. Immediate, functional brainstate assessment is needed to treat patients with acute neurologicalinjury and disease for the prevention of further damage and disability.

SUMMARY

In accordance with the invention, there is provided a neurologicaltriage apparatus comprising a processor configured to process acquiredspontaneous and evoked signals using wavelets.

Also in accordance with the invention, there is provided a method ofdetermining a neurological state of a subject comprising the steps ofacquiring spontaneous signals through an electrode set, processing theacquired signals, extracting desired features from the processedsignals, and classifying the extracted features into one or morediagnostic categories.

Also in accordance with the invention, there is provided a method ofdetermining a neurological state of a subject comprising the steps ofevoking brain response signals using audio, visual, electrical, or otherstimulus means, acquiring the evoked signals through an electrode set,processing the acquired signals, extracting desired features from theprocessed signals, and classifying the extracted features.

Also in accordance with the invention, there is provided a method ofdetermining a neurological state of a subject comprising the steps ofacquiring spontaneous and evoked signals through the electrode set,processing the acquired signals, extracting desired features from theprocessed signals, and classifying the extracted features.

Further in accordance with the invention, there is provided an apparatusfor diagnosing the neurological state of a subject, comprising aprocessor, a memory operatively coupled to the processor, wherein thememory stores one or more operating instructions, a multi-channelinput-output interface operatively coupled to the processor, wherein themulti-channel input-output interface is configured to receive externalelectrical signals through a set of electrodes placed on the subject;and the processor is configured to utilize the one or more operatinginstructions to perform one or more operations on signals received fromthe multi-channel input-output interface.

Also in accordance with the invention, there is provided a kit forperforming an emergency neurological diagnosis of a patient sufferingfrom an altered mental state, the kit including an apparatus fordiagnosing the neurological state of a subject, instructions for usingthe apparatus, and a portable carrying case for the apparatus.

Also in accordance with the invention, there is provided an apparatusfor providing an automatic brain function assessment comprising anelectrode set, a processor, wherein the electrode set and the processorare operatively connected through a multi-channel input-outputinterface, a display operatively connected to the processor, a userinterface operatively connected to the processor, and internal memory,wherein the memory contains instructions for providing a real-timeassessment of a subject's brain function, and the memory containsinstructions for processing signals acquired by the electrode set usingwavelet-packet algorithms.

Also in accordance with the invention, there is provided a method forproviding a triage assessment of a patient's brain function comprisingthe steps of measuring the spontaneous brain activity of the patient,stimulating the patient and measuring the evoked brain activitytherefrom, processing the spontaneous and evoked brain activity, whereinthe processing is performed in real-time using wavelet-packetalgorithms, providing a triage assessment of the patient based on theprocessed brain activity.

Further in accordance with the invention, there is provided a triageapparatus comprising an electrode set, an amplifier operativelyconnected to the electrode set, a processor operatively connected to theamplifier, wherein the processor is configured to process externalsignals acquired by the electrode set using wavelets.

Additional features and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Thefeatures and advantages of the invention will be realized and attainedby means of the elements and combinations particularly pointed out inthe appended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiment of theinvention and together with the description, serve to explain theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flowchart illustrating the method of assessing the brainstate of a subject carried out by an apparatus according to anembodiment consistent with the present invention.

FIG. 2 is a diagram illustrating an apparatus according to an embodimentconsistent with the present invention.

FIG. 3 is a diagram illustrating an electrode set according to anembodiment consistent with the present invention.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to present embodiments of theinvention, an example of which is illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

In accordance with embodiments consistent with the present invention,FIG. 1 shows a flowchart illustrating a method for assessing the brainstate of a patient. This method may be implemented by an apparatus ordevice which is manufactured to perform the method given herein. Anelectrode set is placed on a subject (step 100). Typical electrode setsfor acquiring EEG data use at least 19 electrodes. An electrode setconsistent with an embodiment of the present invention may comprise areduced electrode set, with less than 19 electrodes.

The electrodes measure the electrical fields that are produced as aresult of the subject's brain activity (step 102). The activity may bespontaneous, evoked or a combination thereof. In an embodimentconsistent with the present invention, the spontaneous brain activity ismeasured and an evoked response is measured. The spontaneous activitymay comprise the subject's EEG signals. The evoked response may beobtained by stimulating the subject using visual, physical, auditory, orother stimulation. In an embodiment consistent with the presentinvention, an auditory stimulus is given to the subject to obtain anAuditory Evoked Potential (AEP). Moreover, the Auditory EvokedPotentials may comprise any of auditory brainstem response (ABR)potentials, auditory mid-latency response (AMLR) potentials, or auditorylate response (ALR) potentials, including P100 responses, and P300responses.

The spontaneous and evoked signals are acquired by the electrode set andare subsequently subjected to a signal processor, wherein artifacts areremoved from the signals (step 104). Artifacts that may be removed are aresult of such factors as a disconnected electrode, electromyogram (EMG)artifacts resulting from muscular movement, eye movement and othersignificant artifacts. In one embodiment, the artifacts may be removedby removing discrete artifact sections from the signals. In anotherembodiment, the artifacts may be removed by subtracting out anyartifacts present in the acquired signals.

The artifact-free signals are subjected to further processing to extractstatistical signal features (step 106). In one embodiment consistentwith the present invention, a quantitative EEG algorithm may be used toextract features. In another embodiment, a wavelet packet algorithm maybe used for feature extraction. In a further embodiment, spectralanalysis and statistical procedures may be performed to extractfeatures. In yet a further embodiment, diffusion geometric analysis maybe performed to extract features. In yet another embodiment, microstateanalysis may be performed to extract features. In a further embodiment,wavelet-packet local discriminant basis algorithms may be applied toextract features.

Referring again to FIG. 1, the extracted features are classifiedaccording to one or more diagnostic categories, wherein a probabilitythat features extracted from a subject can be classified in one or morediagnostic categories is determined (step 108). According to embodimentsconsistent with the invention, classifying may be performed by applyingdiscriminant analysis to the extracted features, or by applyingwavelet-packets to the extracted features. Regardless of the classifyingmethod used, the classification algorithm first determined if theresults are normal (step 110). If the features extracted from thesubject's brain waves are normal, then the device will display that thesubject's brain activity is normal (step 122). If there is a higherprobability that the subject's extracted features are not normal, thedevice will attempt to classify the extracted features as an emergencyor “Alert” condition (step 112). If there is a high probability that theextracted features match features typical of someone in an emergencymental state or an “Alert” condition, the device will attempt toclassify the extracted features as either brainstem dysfunction, activeseizure, or burst suppression (step 114). If the device determines thatthe extracted features have a high probability of being one of theemergency states the device will display this result so the subject canreceive immediate treatment (step 122). If the extracted features do nothave a high probability of being an emergency, the device will determineif the abnormality of the extracted features appears to be organic innature (step 116). If the extracted features are determined to correlatewith an extracted feature abnormality that is organic in nature, thedevice will then attempt to determine if the extracted featureabnormality is lateral or global in nature (step 118), and will displaythe result (122). The extracted feature abnormalities will be tested todetermine if they are psychiatric or “functional” in nature (step 120),and this result will be shown (step 122).

FIG. 2 shows an apparatus consistent with an embodiment of the presentinvention. An electrode set 200 is placed on the head of a subject 201.In an illustrative embodiment, the subject is a human, but the subjectcan be an animal as well. An electrode set 200 consistent with anembodiment of the present invention may comprise a reduced electrodeset, with less than 19 electrodes.

FIG. 3 shows an electrode set 200 consistent with an embodiment of thepresent invention. Electrode set 200 may comprise a plurality ofelectrodes which may be affixed to the head of a subject 201. In anillustrative embodiment, electrode set 200 comprises nine electrodesthat may be affixed to the forehead, shoulder and ear of the subject.This reduced electrode set 200 allows for placement on the forehead, andeliminates the need to place any electrodes over any hair that a subjectmay have on their head. This further eliminates any conduction problemsthat arise due to the hair, and also eliminates the need for any hairremoval. In an illustrative embodiment, the electrodes may be placed onthe right mastoid 302, far right of the forehead 304, near right of theforehead 306, center top of the forehead 308, near left of the forehead310, far left of the forehead 312, left mastoid 314, and an ECGelectrode on the left shoulder 316. Additionally, in an illustrativeembodiment, there is an electrode placed on the center of the forehead318 that is grounded. The electrodes on the right and left mastoids 302,314 and the center of the forehead 318 may be used in an embodimentwherein an AEP signal is acquired. An illustrative embodiment consistentwith the present invention is able to use an electrode set 200 with areduced number of electrodes because the signal processing algorithmseliminate the need for additional electrodes.

Referring back to FIG. 2, the electrodes measure the electrical fieldsthat are produced as a result of subject's 201 brain activity. Theactivity may be spontaneous, evoked or a combination thereof. In anembodiment consistent with the present invention, the spontaneous brainactivity is measured, for example the EEG of subject 210, and an evokedresponse is measured. The evoked response may be obtained by stimulatingsubject 201 using visual, physical, aural or other stimulation. In anembodiment consistent with the present invention, an auditory stimulusis given to subject 201 to obtain an Auditory Evoked Response (AEP). Inone embodiment of the present invention, a pulse oximeter 203 isconnected to subject 201 to monitor subject's 201 pulse and blood oxygenlevels 209.

Electrode headset 202 and pulse oximeter 203 can be connected to ahandheld device 205. Electrode headset 202 can be connected to handhelddevice 205 through a low-voltage preamplifier 222. Low-voltagepreamplifier 222 has a high noise tolerance and is designed to amplifythe signals that are transmitted to and from electrode headset 202.Handheld device 205 is designed to be able to fit in one's hand. In oneembodiment handheld device 205 may have a size of about 115 mm×190 mm×60mm, and a weight of less than about 600 g. Handheld device 205 has adisplay 219, which can be an LCD screen, and can further have a touchscreen interface and a traditional user interface 220 such as akeyboard. In one embodiment, handheld device 205, electrodes 200 andelectrode headset 202 may come in a kit, designed for performingneurological triage of a patient suffering from an altered mental state,wherein the kit includes instructions for using handheld device 205, andcomes in a portable carrying case.

Handheld device 205 contains analog and digital hardware on the frontend 221, and is controlled through processor 210. In one embodiment,processor 210 is a Texas Instruments OMAP microcontroller/digital signalprocessor. Front end 221 is separated from processor 210 by isolationbarrier 208. Front end 221 acts as a multi-channel input/outputinterface for the device, further facilitating the bi-directionalcommunication of transmitted and received signals to processor 210. Inone embodiment consistent with the present invention, the multi-channelinput/output interface is a wireless multi-channel input/outputinterface.

In an embodiment consistent with the present invention, a command from auser, entered through user interface 220, will begin a test routine.Analog brain waves are acquired through electrode headset 202 and aretransmitted through cables to analog front end 204 of handheld device205. Analog brain waves are then converted to digital signals through anADC contained in analog front end 204 and transmitted to digital frontend 206. Digital front end 206 transmits the digital signals toprocessor 210 where digital signals are processed in accordance withinstructions contained in internal memory 211 of processor 210. In anembodiment consistent with the present invention, the signals areprocessed to remove noise, processed to extract features, and processedto classify the extracted features. In another embodiment, theinstructions contained in internal memory 211 of processor 210 compriseinstructions for performing the method illustrated in FIG. 1. Processor210 may then output results, which may be in real-time, concerning theassessment of subject's 201 brain in accordance with the classification.Outputs may be displayed on LCD screen 219 of handheld device 205, ormay be saved to external memory 216, or may be displayed on PC 215connected to handheld device 205 by serial or universal serial busconnection. In one embodiment, display may display a representation ofsubject's 201 brain based on the assessment. In another embodimentconsistent with the present invention, processor 210 transmits the raw,unprocessed brainwaves to an external memory 216. External memory 216may be a hard disk drive, an optical disk drive, a floppy disk drive, ora removable, non-volatile memory device. In another embodiment, resultsare transmitted through serial bus to infrared transmitter 217 which isconfigured to transmit data wirelessly to printer 218 to wirelesslyprint results. Handheld device 205 contains an internal rechargeablebattery 212 that is able to be charged during use or in between usesthrough charger 213 connected to a typical AC outlet 214.

In another embodiment, a test routine may require a stimulus to be givento subject 200 to evoke a response. The command to produce a stimulus istransmitted from the processor 210 to digital front end 206, where it isconverted to an analog signal by a DAC contained therein. The analogsignal is output from the analog front end 204 through the cables and toa stimulus emitter 224 which stimulates subject 201. The stimulus can beauditory, sensory, or visual, or other. In a preferred embodiment, thestimulus is an auditory stimulus given through transmitters that areplaced in subject's ear. The stimulus emitter 224 may be an EtymoticResearch ER 10D probe with dual speakers and a single microphone in eachear. The evoked signal is acquired by electrode headset 202, and istransmitted along with spontaneous signals to analog front end 204 ofhandheld device 205, where it is converted to a digital signal andtransmitted to digital front end 206. Digital front end 206 transmitsthe digital acquired signals to processor 210, where evoked responsesignals are filtered out from spontaneous signals. In an embodimentconsistent with the present invention, the evoked response signals arefiltered out using an adaptive wavelet based filter. More specifically,internal memory 211 can contain instructions that are executed by theprocessor 210 which uses a Dual-Tree Complex Wavelet Transform as aninvertible transform to adaptively filter evoked signal response signalsfrom spontaneous response signals. The instructions further can containan implementation of an algorithm carried out by processor 210, whereina complex wavelet transform is computed for each sub-average, and thenthe phase variance of each normalized wavelet coefficient w_(i,j) iscomputed. The magnitude of each wavelet coefficient is selectivelyscaled according to the phase variance of the coefficients at thislocation across the sub-averages. The scaling has the form:w _(i,j)=α_(i,j) W _(i,j)exp(jθ _(i,j)),where W_(i,j) and θ_(i,j) are respectively the magnitude and phase ofthe unprocessed complex i^(th) wavelet coefficient at the j^(th) scale,and where:α_(i,j)=exp(−0.75(F _(ij) /T _(max))⁴,where F_(ij) is the phase variance of coefficient w_(i,j) across thesub-averages. The filtered evoked signal is averaged and an automaticpeak detection algorithm is implemented by processor 210 to determinethe following peak locations and latencies: Peak 1, Peak 2, andInterpeak 1-5 latency. These values are then compared to normative datacontained in internal memory 211 of processor 210.

In an embodiment consistent with the present invention, processing thesignals comprises removing noise from the acquired signals, or“de-noising.” Internal memory 211 of processor 210 contains instructionsfor instructing processor 210 to perform an algorithm on acquiredsignals. In one embodiment, the algorithm utilizes wavelet based signalprocessing using wavelet transforms. The wavelet transform, a member ofthe family of Fourier transforms, is a process of decomposing a givensignal into a set of orthonormal basis functions called wavelets. Intraditional discrete Fourier transform (DFT), a signal is decomposedusing complex sinusoids as basis functions, producing a frequency domainrepresentation of the signal. In contrast, a discrete wavelet transform(DWT) uses a family of specifically designed wavelets, or little waves,as basis functions. A family of wavelets is created by dilating theoriginal wavelet function, termed the “mother wavelet.” A wavelettransform decomposes the signal in both time and frequency usingdifferent dilations of the mother wavelet. With the application of DWT,the one dimensional finite signal x[n] is represented in two-dimensional“wavelet coordinates.” Individual levels of signal decomposition arecreated, called scales. At each scale a set of coefficients is createdby computing the inner product of the original signal x[n] with a scaledversion of the mother wavelet. The mother wavelet function is designatedby Ψ, and its dilations are designated by Ψ(j). The position index of awavelet at scale j is called a translation. The value of the wavelet iscompletely described by the two dimensional sequence Ψ(j,k), where j isthe scale index of the wavelet, and k is the translation index. The DWTis the defined as:

${{C\left( {j,k} \right)} = {\sum\limits_{n = 0}^{N - 1}\;{{x\lbrack n\rbrack}{\Psi_{j,k}\lbrack n\rbrack}}}},{{{where}\mspace{14mu}{\Psi_{j,k}\lbrack n\rbrack}} = {2^{\frac{- j}{2}}{\Psi\left( {{2^{- j}n} - k} \right)}}}$

Coefficients C(j,k) are the wavelet coefficients at different scales jand translations k of the inner product of the wavelet Y(j,k) with theoriginal signal x[n]. In wavelet coordinates, information about both thefrequency and the location (time) of the signal energy is preserved.This is a process of noise suppression that utilizes assumptions aboutsmoothness and coherence properties of both the underlying signal andthe noise that contaminates it. Similar to filtering in the frequencydomain, the wavelet coefficient thresholding algorithm reduces sets ofwavelet coefficients in the wavelet domain. This process is based on theassumption that the underlying signal is smooth and coherent, while thenoise that is mixed with the signal is rough and incoherent. Smoothnessof a signal is a property related to its bandwidth, and is defined inrelation to how many times a signal can be differentiated. The degree ofsmoothness is equal to the number of continuous derivatives that can becalculated. A signal is coherent if its energy is concentrated in bothtime and frequency domains. An incoherent noise is “spread out,” and notconcentrated. One measure of coherence is how many wavelet coefficientsare required to represent 99% of the signal energy. A time-frequencysignal space is completely spanned by wavelet coefficients at all scalesand translations. A well-concentrated signal decomposition in anappropriately selected wavelet basis will require very few coefficientsto represent 99% of signal energy. However, a completely incoherentnoise will require 99% of the coefficients that span the entire space torepresent 99% of its energy.

This conventional wavelet de-noising process is a three step process:

-   -   1. Wavelet transform the signal to obtain wavelet coefficients        at different scales    -   2. Threshold the coefficients and set to zero any smaller than a        threshold δ    -   3. Perform the inverse wavelet transform to approximate the        original signal

In the de-noising process, the noise components of the signal areattenuated by selectively setting the wavelet coefficients to zero.De-noising is thus a non-linear operation, because differentcoefficients are affected differently by the thresholding function.There are many parameters to control in this algorithm: level of waveletdecomposition, threshold selection, using different thresholds atdifferent wavelet coefficients that are kept by a fixed amount.

In accordance with an embodiment of the present invention, thede-noising process involves dividing the acquired signals into discreteintervals, or “frames,” and then averaging the frames, and de-noisingthe averaged frames. The greater amount of frames that are de-noisedprior recomposing the signal, the better the results of the de-noisingprocess. Preferably, the frames are combined by using two adjacentframes and calculating their linear average. This method is chosen forits simplicity, computational stability, and well-understood behavior.This dyadic linear average is then de-noised, and a new frame iscreated. The overall idea is to generate as many permutations of theoriginal arrangement of frames as possible, and keep averaging andde-noising those new combinations of frames. This recombination processis a tree-like process, and may comprise the dual-tree process describedabove, in which new levels of recombined frames are created. The averageand de-noise operation creates frames at level k, which are no longer alinear combination of frames from level k−1.

The many possible algorithms to accomplish this task can be evaluated bydifferent criteria: ease of implementation, computational efficiency,computational stability, etc. For the present invention, ease ofimplementation is used, because the key aspect of the invention isimplementation of different wavelet de-noising techniques and notcombinatorics of frame rearrangements. The goal of the preferredembodiment in frame rearranging is to produce enough new frames toobtain acceptable performance.

Processor 210 is further configured to execute instructions contained ininternal memory 211 to perform an algorithm for extracting signals fromprocessed signals. In one embodiment, processor 210 executesinstructions which performs a quantitative EEG (QEEG) feature extractionalgorithm on the processed signals. The algorithm utilizes Fast FourierTransform (FFT) Analysis is applied to characterize the frequencycomposition of the processed signals, typically dividing the signalsinto the traditional frequency bands: delta (1.5-3.5 Hz), theta (3.5-7.5Hz), alpha (7.5-12.5 Hz), beta (12.5-25 Hz), and gamma (25-50 Hz).Higher EEG frequencies, up to and beyond 1000 Hz may also be used. Thesefeatures can include characteristics of the processed signals such asabsolute and relative power, symmetry, and coherence. In the context ofanalyzing process brainwaves, absolute power is the average amount ofpower in each frequency band and in the total frequency spectrum of theprocessed signals, and is a measure of the strength of the brain'selectrical activity. Relative power is the percentage of the total powercontributed for a respective electrode and a respective frequency bandand is a measure of how brain activity is distributed. Symmetry is theratio of levels of activity between corresponding regions of the twobrain hemispheres in each frequency band and is a measure of the balanceof the observed activity. Coherence is the degree of synchronization ofelectrical events in corresponding regions of the two hemispheres and isa measure of the coordination of the brain activity. These four basiccategories of univariate features, resulting from the spectral analysisof the process signals, are believed to characterize independent aspectsof brain activity and each is believed to be sensitive to a variety ofdifferent clinical conditions and changes of state. A full set ofindividual and pairwise features is calculated and transformed forGaussianity using, for example, the log function. Once a Gaussiandistribution has been demonstrated and age regression applied,statistical Z transformation is performed. The Z-transform is used todescribe the deviations from age expected normal values:

Z = Probability  that  subject  value  lies  within  the  normal  range$Z = \frac{{{Subject}\mspace{14mu}{Value}} - {{Norm}\mspace{14mu}{for}\mspace{14mu}{Age}}}{{Standard}\mspace{14mu}{Deviation}\mspace{14mu}{for}\mspace{14mu}{Age}}$

The significance of the Z-transform is that it allows measures withdifferent metrics to be combined using the common metric of probability.Using a database of response signals from a large population of subjectsbelieved to be normal, or to have other conditions, the distribution ofthese response signals is determined for each electrode. In particular,each extracted feature or factor score is converted to a Z-transformscore, or factor Z-score which characterizes the probability that theextracted feature value or factor score observed in the subject willconform to a normal value.

Processor 210 is further configured to perform an algorithm wherein theextracted features, or the Z-scores are classified. In one embodiment,these sets of univariate data is subjected to Gaussian normalization inorder to improve the accuracy of any subsequent statistical analysis.The Z-scores are given a selected discriminant score. Each discriminantscore is a respective weighted combination of a selected subset ofZ-scores for monopolar and/or bipolar univariate and multivariatefeatures derived from the processed signals of a subject. The processor210 executes an algorithm wherein a respective discriminant score isevaluated for each of two or more diagnostic categories multiplying eachof several selected Z-scores by a respective coefficient and adding theresulting products. The coefficients typically differ as betweendiagnostic categories and as between Z-scores. The probability isevaluated that the subject belongs to one of the two or more diagnosticcategories through a probability evaluating expression which is afunction of the relevant discriminant scores, matching results againstlimits provided by internal memory 211 for selected brain states.

The diagnostic categories may be indicative of whether a subject isexhibiting normal or abnormal brain function. Moreover, abnormal brainfunction may be further broken down into diagnostic categories which areindicative of psychiatric or “functional” in nature, organic in nature,either lateral or global, or an emergency or “Alert” condition, whichmay include seizure, abnormal brainstem response, or burst suppression.Psychiatric or “functional” brain function may further be broken downinto specific diagnostic categories indicative of specific types ofpsychiatric disorders. Similarly, organic lateral and global brainfunctions may further be broken down into specific diagnostic categoriesindicative of specific types of lateral and global abnormalities. Theability of the apparatus to determine a probability that subject 201 isexperiencing a particular type of abnormal brain function allows amedical professional to act accordingly. For example, should a subjectbe diagnosed as having a high probability of having a brain functionthat is indicative of an organic abnormality, the apparatus will furtherdetermine whether the brain function has a higher probability of beingindicative of a lateral or global abnormality, allowing a medicalprofessional to distinguish between global abnormalities such asconcussion, toxicity, encephalitis and the like, and lateralabnormalities such as ischemic and hemorrhagic strokes. This probabilitythat subject 201 belongs to a particular diagnostic category can bedisplayed on LCD display 219. For example, in the above scenario inwhich subject 201 is exhibiting an organic, lateral abnormality, LCDdisplay 219 can further display that subject's brain function is 80%indicative of a hemorrhagic stroke, 15% indicative of an ischemicstroke, and 5% of a subdural hematoma. Furthermore, if a subject 201 isdiagnosed as having a high probability of suffering from an emergency or“Alert” condition, such as active seizure, a medical professional may beable to provide immediate emergency care to subject 201.

The novel apparatus and method allows the rapid triage assessment of theneurological state of a subject, allowing for immediate diagnosis andcare of victims of head injury and neurological maladies. The apparatusmay further be packaged in a portable kit with instructions on using theapparatus for performing rapid triage assessment.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. An apparatus for determining the neurologicalstate of a subject, comprising: a set of electrodes configured to beplaced on the subject to collect brain electrical signals; a processor;a memory operatively coupled to the processor, wherein the memory storesone or more operating instructions; and an input-output interface havingat least one channel operatively coupled to the processor, wherein theinput-output interface is configured to receive brain electrical signalsthrough the set of electrodes; and the processor is configured toutilize the one or more operating instructions to perform one or moreoperations on the signals received through the input-output interface,wherein the one or more operations comprise: de-noising the receivedsignals; extracting features from the de-noised signals; classifying theextracted features; and determining a neurological state of the subjectbased on the classification, wherein determining the neurological statecomprises the steps of: determining if the neurological state is normalor abnormal; and determining if an abnormal neurological state ispsychiatric or “functional” in nature, organic in nature, or anemergency or “Alert” condition.
 2. The apparatus of claim 1, furthercomprising: a display device, wherein the display device is operativelyconnected to the processor and the processor is further configured todisplay results of the one or more operations on the display device. 3.The apparatus of claim 1, further comprising: a bi-directionalcommunications channel operatively connected to the input-outputinterface and to the processor to communicate the received signals. 4.The apparatus of claim 1, further comprising: a low voltage preamplifierhaving at least one channel operatively connected to the input-outputinterface.
 5. The apparatus of claim 4, wherein the low voltagepreamplifier has a high noise tolerance.
 6. The apparatus of claim 1,wherein the input-output interface includes an electroencephalographtesting interface and an auditory evoked potentials testing interface;and wherein the processor is configured with the one or more storedoperating instructions for auditory tests selected from the groupcomprising electroencephalograph test procedures, auditory evokedpotentials test procedures, and combinations thereof.
 7. The apparatusof claim 1, wherein the processor has an internal memory, and theprocessor is configured to utilize the internal memory to execute one ormore operating instructions for processing the received signals.
 8. Theapparatus of claim 1, wherein the extracted features are classifiedusing discriminant analysis.
 9. The apparatus of claim 1, wherein theinstructions for denoising the signals include instructions to filterthe received signals.
 10. The apparatus of claim 9, wherein thefiltering comprises: using a dual-tree complex wavelet transform of thereceived signals.
 11. The apparatus of claim 1, wherein the set ofelectrodes comprises: a plurality of electrodes configured to be placedon the subject's forehead; and at least one electrode configured to beplaced in at least one of the ears of the subject.
 12. The apparatus ofclaim 1, further comprising: a stimulation device operatively connectedto the input-output interface for evoking an auditory potential in thesubject.
 13. The apparatus of claim 1, wherein the apparatus is housedin a hand-held enclosure.
 14. The apparatus of claim 1, wherein theinput-output interface further comprises: a wireless input-outputinterface having at least one channel.
 15. A kit for performing anemergency neurological diagnosis of a patient suffering from an alteredmental state, the kit including: the apparatus of claim 1; instructionsfor using the apparatus; and a portable carrying case for the apparatus.16. An apparatus for providing an automatic brain function assessmentcomprising; an electrode set; a processor; wherein the electrode set andthe processor are operatively connected through an input-outputinterface having at least one channel; a display operatively connectedto the processor; a user interface operatively connected to theprocessor; and internal memory, wherein the memory contains instructionsfor providing a real-time assessment of whether a subject's brainfunction is normal or abnormal; and wherein the memory contains furtherinstructions for providing a real-time assessment of whether an abnormalbrain function is psychiatric or “functional”′ in nature, organic innature, or an emergency or “Alert” condition.